Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this pilot study is to compare parent and infant outcomes and unit outcomes pre and post a planned unit-wide intervention aimed at increasing parent presence in the Neonatal Intensive Care Unit (NICU). The FCC intervention will consist of communicating an expectation that all NICU parents be present at minimum 4 hours/day versus the current practice of telling families to "come as much as they can" that has resulted in inconsistent parent presence.
Family centered care (FCC) is becoming the standard of care in the Neonatal Intensive Care Unit (NICU) and many benefits of FCC programs are reported in the literature. However, the integration of FCC practices remains inconsistent in NICUs and many families do not fully access available FCC supports. As a result NICU families continue to report feelings of powerlessness, stress, depression and lack of confidence in their ability to care for their infants at home. Studies of increased family presence in the NICU (8hours/day and 24/hours/day) have reported promising results for infants and families, but these studies report on programs implemented outside of the US. It is not known whether a program requiring fewer hours/day of parent presence, which may be a better fit with current US family demographics and policies, would demonstrate similar benefits. The purpose of this pilot study is to compare parent and infant outcomes and unit outcomes pre and post a planned unit-wide intervention aimed at increasing parent presence in the NICU. The FCC intervention will consist of communicating an expectation that all NICU parents be present at minimum 4 hours/day versus the current practice of telling families to "come as much as they can" that has resulted in inconsistent parent presence. Following informed consent, data will be collected on up to 45 NICU infants and families pre- and post- the intervention for a total sample of up to 90. Infant measures will include Salivary Cortisol levels, Infant weight gain, Length of Stay and Feeding route at discharge as well as rates of Family Visiting, Traditional Holding, Kangaroo Care (KC), and Breastfeeding. Parent measures will include Salivary Cortisol Levels and reported stress using the Parent Stress Scale: NICU. Unit-wide data will also be collected pre- and post- the intervention. Unit wide measures will include rates of Visitation, KC, Breastfeeding, Nosocomial Infections, IV infiltrates, Medication Errors and Incident (SERS) report rates.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-FCC Intervention | No Intervention | Pre-intervention group. No intervention will be administered. | |
| Post-FCC Intervention | Active Comparator | Following unit-wide implementation of FCC intervention consisting of communicating to families an expectation that they spend 4 hours per day in the NICU with their infants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FCC intervention | Other | Communication to all NICU families that they should be in the NICU a minimum of 4 hours/day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Parent Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU) | Measured at baseline (NICU admission, from birth to 2 weeks of infant age) and at NICU discharge, an average of 47 days using validated Parent Stressor Scale: Neonatal Intensive Care Unit. Measure uses a 5 level Likert scale from not experienced (0) to extremely stressful (4). Higher score indicated more stress experienced. Total score used was calculated using average of subscale scores. Total score range also 0-4 units on scale. | Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days. |
| Infant Salivary Cortisol | Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days in Nanograms per milliliter (ng/ml). | Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days. |
| Family Visiting Rate | Rate of family visiting in hours per day | Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay in Days | Infant length of stay in days in the NICU. Measured from baseline (NICU admission at birth) to NICU discharge (an average of 47 days). | Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days. |
| Parent Kangaroo Care Rate |
| Measure | Description | Time Frame |
|---|---|---|
| Infant Weight Gain in Grams/Day | Average weight gain in grams/day measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days. | Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susan M Horner, MS | Ann & Robert H Lurie Children's Hospital of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatal Intensive Care Unit, Children's Memorial Hospital | Chicago | Illinois | 60148 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18034178 | Result | Cooper LG, Gooding JS, Gallagher J, Sternesky L, Ledsky R, Berns SD. Impact of a family-centered care initiative on NICU care, staff and families. J Perinatol. 2007 Dec;27 Suppl 2:S32-7. doi: 10.1038/sj.jp.7211840. | |
| 21255703 | Result | Gooding JS, Cooper LG, Blaine AI, Franck LS, Howse JL, Berns SD. Family support and family-centered care in the neonatal intensive care unit: origins, advances, impact. Semin Perinatol. 2011 Feb;35(1):20-8. doi: 10.1053/j.semperi.2010.10.004. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
78 infants; 78 of the infants' mothers; 35 of the infants' fathers
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pre-FCC Intervention | Pre-intervention group. No intervention will be administered. |
| FG001 | Post-FCC Intervention | Following unit-wide implementation of FCC intervention consisting of communicating to families an expectation that they spend 4 hours per day in the NICU with their infants. FCC intervention: Communication to all NICU families that they should be in the NICU a minimum of 4 hours/day. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 31, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Rate of Kangaroo Care (skin to skin holding of infant by a parent) in hours per day |
| Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days. |
| Mothers Breastfeeding Rate | Number of mothers providing breastmilk at NICU discharge | Measured at NICU discharge, an average of 47 days from NICU admission. |
| Ann & Robert H Lurie Childrens Hospital of Chicago |
| Chicago |
| Illinois |
| 60611 |
| United States |
| 23412640 | Result | Reynolds LC, Duncan MM, Smith GC, Mathur A, Neil J, Inder T, Pineda RG. Parental presence and holding in the neonatal intensive care unit and associations with early neurobehavior. J Perinatol. 2013 Aug;33(8):636-41. doi: 10.1038/jp.2013.4. Epub 2013 Feb 14. |
| 15737221 | Result | Franck LS, Cox S, Allen A, Winter I. Measuring neonatal intensive care unit-related parental stress. J Adv Nurs. 2005 Mar;49(6):608-15. doi: 10.1111/j.1365-2648.2004.03336.x. |
| NICU Infants |
|
| Mothers of Enrolled Infants |
|
| Fathers of Enrolled Infants |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Pre-FCC intervention analyzed 40 infants, 40 mothers and 20 fathers (or 60 total parents) Post-FCC intervention analyzed 38 infants, 38 infants and 15 fathers (or 53 total parents)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pre-FCC Intervention | Pre-intervention group. No intervention was administered. |
| BG001 | Post-FCC Intervention | Following unit-wide implementation of FCC intervention consisting of communicating to families an expectation that they spend 4 hours per day in the NICU with their infants. FCC intervention: Communication to all NICU families that they should be in the NICU a minimum of 4 hours/day. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Gestational age in weeks of infants at birth | Population differs in that only enrolled Infants reported here (N=78; 40 pre, 38 post-intervention). | Mean | Standard Deviation | weeks |
| |||||||||||||
| Age, Continuous | Mothers and fathers ages in years | Numbers differ from overall because only enrolled Mothers (N=78; 40 pre, 38 post-intervention) and enrolled Fathers (N=35; 20 pre, 15 post-intervention) are reported here. | Mean | Standard Deviation | years |
| |||||||||||||
| Sex: Female, Male | Infant sex N=78 (40 pre; 38 post) Mothers' sex N=78 (40 pre; 38 post) Fathers' sex N=35 (20 pre; 15 post) | Count of Participants | Participants |
| |||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Birth weight | Infant data only. N=40 pre-intervention; N=38 post-intervention | Only infants birth weights analyzed. N=40 (pre) and 38 (post) | Mean | Standard Deviation | grams |
| |||||||||||||
| Infants Neonatal Medical Index | A scale measuring infant level of illness from 1 (least severe) to 5 (most severe) | Only infant participants measured using Neonatal Medical Index Pre-intervention = 40; Post-intervention = 38 | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Parent Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU) | Measured at baseline (NICU admission, from birth to 2 weeks of infant age) and at NICU discharge, an average of 47 days using validated Parent Stressor Scale: Neonatal Intensive Care Unit. Measure uses a 5 level Likert scale from not experienced (0) to extremely stressful (4). Higher score indicated more stress experienced. Total score used was calculated using average of subscale scores. Total score range also 0-4 units on scale. | Enrolled mothers and fathers | Posted | Mean | Standard Deviation | score on a scale | Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Infant Salivary Cortisol | Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days in Nanograms per milliliter (ng/ml). | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/ml) | Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Family Visiting Rate | Rate of family visiting in hours per day | Analysis conducted per infant | Posted | Mean | Standard Deviation | hours per day | Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Length of Stay in Days | Infant length of stay in days in the NICU. Measured from baseline (NICU admission at birth) to NICU discharge (an average of 47 days). | Enrolled infants | Posted | Mean | Standard Deviation | days | Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Parent Kangaroo Care Rate | Rate of Kangaroo Care (skin to skin holding of infant by a parent) in hours per day | Enrolled infants | Posted | Mean | Standard Deviation | hours per day | Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days. |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mothers Breastfeeding Rate | Number of mothers providing breastmilk at NICU discharge | Population differs in that only enrolled mothers were analyzed (N=78; 40 pre, 38 post) | Posted | Count of Participants | Participants | Measured at NICU discharge, an average of 47 days from NICU admission. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Infant Weight Gain in Grams/Day | Average weight gain in grams/day measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days. | Posted | Mean | Standard Deviation | grams/day | Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days. |
|
|
Measured at baseline (NICU admission at birth) and at NICU discharge, an average of 47 days.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-FCC Intervention | Pre-intervention group. No intervention will be administered. | 0 | 100 | 0 | 100 | 0 | 100 |
| EG001 | Post-FCC Intervention | Following unit-wide implementation of FCC intervention consisting of communicating to families an expectation that they spend 4 hours per day in the NICU with their infants. FCC intervention: Communication to all NICU families that they should be in the NICU a minimum of 4 hours/day. | 0 | 91 | 0 | 91 | 0 | 91 |
Not provided
Not provided
Use of electronic medical record (EMR) data may have resulted in biased documentation.
EMR data did not differentiate between maternal and paternal presence and kangaroo care.
EMR data may have inflated parent presence and kangaroo care numbers in that nurses may have documented "present" instead of a time during an hour.
Single site study.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan Horner, Developmental Specialist, NICU | Ann & Robert H. Lurie Children's Hospital | 13122271452 | shorner@luriechildrens.org |
| Feb 22, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D001903 | Bottle Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
Not provided
Not provided
|
| Fathers |
|
|
|
| Mothers' sex |
|
|
| Fathers' sex |
|
|
|
|
|
|
| At NICU discharge, average 47 days |
|
|
Null hypothesis: There are no significant differences between fathers' PSS:NICU scale scores pre- and post-FCC intervention. |
| ANOVA |
Repeated measures ANOVA |
| =0.005 |
a priori threshold for statistical significance p<.05 |
| F - value |
| 9.32 |
| 2-Sided |
| Equivalence |
No defined equivalence margin. |
|
|
|
|
|
|
|
|
|
|
|